- April 26, 2017
9:00 am - 4:30 pm
LocationHoliday Inn & Suites Pointe-Claire Montréal Aéroport
This course is intended to provide a basic overview of post-market adverse drug reaction reporting requirements in Canada.
1. Introduction to Pharmacovigilance
This section introduces the audience to Pharmacovigilance, its scope and the international standardization of the Reporting of Adverse Drug Reactions.
2. Post-Marketing Adverse Drug Reaction Reporting in Canada- Individual Case Safety Reports
This section includes a presentation and a discussion on the Canadian Food and Drug Regulations and Health Canada’s guidances for the reporting of adverse drug reactions occurring in the Post-Approval period.
3. Post-Marketing Adverse Drug Reaction Reporting in Canada – Summary Reports
This section includes a presentation and a discussion on the Canadian Food and Drug Regulations and Health Canada’s guidance for the reporting of annual summary reports and issue-related summary reports in the Post-Approval period.
4. Risk Management Plans in Canada
A brief overview of Risk Management Plan requirements in Canada will be provided
5.Good Pharmacovigilance Practice (GVP) Inspections in Canada
This section will review Health Canada’s GVP inspection process and will provide participants with useful tips to prepare for inspections.
Who should attend?
Individuals in Drug Safety/Pharmacovigilance, Regulatory Affairs and Quality Assurance who have limited or no pharmacovigilance experience. It can also serve as a refresher course for individuals with more experience in Pharmacovigilance.
Executive Director, PV Rita Cassola is recognized as an expert and a leader in the area of pharmacovigilance. Rita is a registered pharmacist with over 15 years of experience in global and Canadian pharmacovigilance and medical information. Prior to co-founding Certus PV Services, Rita spent 5 years in increasingly senior consultant roles at CanReg/OptumInsight. In her role of Senior Director PV, Rita routinely provided expert pharmacovigilance guidance to pharmaceutical companies in Canada. She acted as the lead auditor in several audits and assisted companies in preparing for GVP inspections. Rita was also instrumental in setting up pharmacovigilance systems for Canadian companies. Rita’s earlier work experience includes 10 years at Novartis Consumer Health in Canada and in Switzerland, including a global senior management role in aggregate reporting and case processing. In addition, Rita is engaged in teaching pharmacovigilance courses to the industry. Rita is a member of the Drug Information Association (DIA) and the Canadian Pharmacovigilance Network and has presented at several conferences/webinars organized by these professional associations.
Registration Deadline: 24 Apr 2017